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NCT ID: NCT02993523 Active, not recruiting - Clinical trials for Acute Myeloid Leukemia (AML)

A Study of Venetoclax in Combination With Azacitidine Versus Azacitidine in Treatment Naïve Participants With Acute Myeloid Leukemia Who Are Ineligible for Standard Induction Therapy

Viale-a
Start date: February 2, 2017
Phase: Phase 3
Study type: Interventional

Acute Myeloid Leukaemia (AML) is an aggressive and rare cancer of myeloid cells (a white blood cell responsible for fighting infections). Successful treatment of AML is dependent on what subtype of AML the participant has, and the age of the participant when diagnosed. Venetoclax is an experimental drug that kills cancer cells by blocking a protein (part of a cell) that allows cancer cells to stay alive. This study is designed to see if adding venetoclax to azacitidine works better than azacitidine on its own. This is a Phase 3, randomized, double-blind (treatment is unknown to participants and doctors), placebo controlled study in patients with AML who are >= 18 or more years old and have not been treated before. Participants who take part in this study should not be suitable for standard induction therapy (usual starting treatment). AbbVie is funding this study which will take place at approximately 180 hospitals globally and enroll approximately 400 participants. In this study, 2/3 of participants will receive venetoclax every day with azacitidine and the remaining 1/3 will receive placebo (dummy) tablets with azacitidine. Participants will continue to have study visits and receive treatment for as long as they are having a clinical benefit. The effect of the treatment on AML will be checked by taking blood, bone marrow, scans, measuring side effects and by completing health questionnaires. Blood and bone marrow tests will be completed to see why some people respond better than others. Additional blood tests will be completed for genetic factors and to see how long the drug remains in the body.

NCT ID: NCT02973789 Active, not recruiting - NSCLC Clinical Trials

Effect of Tumor Treating Fields (TTFields) (150 kHz) Concurrent With Standard of Care Therapies for Treatment of Stage 4 Non-small Cell Lung Cancer (NSCLC) Following Platinum Failure (LUNAR)

Start date: December 2016
Phase: Phase 3
Study type: Interventional

The study is a prospective, randomized controlled phase III trial aimed to test the efficacy and safety of TTFields, using the NovoTTF-200T device, concurrent with standard therapies for stage 4 NSCLC patients, following progression while on or after platinum based treatment. The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.

NCT ID: NCT02970318 Active, not recruiting - Clinical trials for Chronic Lymphocytic Leukemia

A Study of Acalabrutinib vs Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in R/R CLL

Start date: February 2, 2017
Phase: Phase 3
Study type: Interventional

This study is designed to evaluate the efficacy of acalabrutinib compared with rituximab in combination with idelalisib or bendamustine in previously treated subjects with chronic lymphocytic leukemia (CLL).

NCT ID: NCT02963025 Active, not recruiting - Clinical trials for One-Lung Ventilation

Protective Ventilation With High Versus Low PEEP During One-lung Ventilation for Thoracic Surgery

Start date: January 2017
Phase: N/A
Study type: Interventional

One-lung ventilation (OLV) with resting of the contralateral lung may be required to allow or facilitate thoracic surgery. However, OLV can result in severe hypoxemia, requiring a mechanical ventilation approach that is able to maintain adequate gas exchange, while protecting the lungs against postoperative pulmonary complications (PPCs). During OLV, the use of lower tidal volumes is helpful to avoid over-distension, but can result in increased atelectasis and repetitive collapse-and-reopening of lung units, particularly at low levels of positive end-expiratory pressure (PEEP). Anesthesiologists inconsistently use PEEP and recruitment maneuvers (RM) in the hope that this may improve oxygenation and protect against PPC. Up to now, it is not known whether high levels of PEEP combined with RM are superior to lower PEEP without RM for protection against PPCs during OLV. Hypothesis: An intra-operative ventilation strategy using higher levels of PEEP and recruitment maneuvers, as compared to ventilation with lower levels of PEEP without recruitment maneuvers, prevents postoperative pulmonary complications in patients undergoing thoracic surgery under standardized one-lung ventilation.

NCT ID: NCT02951650 Active, not recruiting - Crohn Disease Clinical Trials

Long Term Observational Study of a Vagal Nerve Stimulation Device in Crohn's Disease

Start date: January 2015
Phase: Phase 1/Phase 2
Study type: Interventional

This will be an open label multicenter study of the safety and efficacy of an active implantable VNS device in patients with Crohn's Disease.

NCT ID: NCT02914535 Active, not recruiting - Ulcerative Colitis Clinical Trials

Filgotinib in Long-Term Extension Study of Adults With Ulcerative Colitis

SELECTIONLTE
Start date: February 23, 2017
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to observe the long-term safety of filgotinib in adults who have completed or met protocol specified efficacy discontinuation criteria in a prior filgotinib treatment study in ulcerative colitis (UC).

NCT ID: NCT02831959 Active, not recruiting - Clinical trials for Brain Metastases From Non-small Cell Lung Cancer (NSCLC)

Pivotal, Open-label, Randomized Study of Radiosurgery With or Without Tumor Treating Fields (TTFields) for 1-10 Brain Metastases From Non-small Cell Lung Cancer (NSCLC).

Start date: July 2016
Phase: Phase 3
Study type: Interventional

The study is a prospective, randomized controlled phase III trial, to test the efficacy, safety and neurocognitive outcomes of advanced NSCLC patients, following stereotactic radiosurgery (SRS) for 1 inoperable brain metastasis or 2-10 brain metastases, treated with NovoTTF-200M and supportive treatment compared to supportive treatment alone. The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.

NCT ID: NCT02763319 Active, not recruiting - Clinical trials for Diffuse Large B-cell Lymphoma

A Trial to Evaluate the Efficacy and Safety of Tafasitamab With Bendamustine (BEN) Versus Rituximab (RTX) With BEN in Adult Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

B-MIND
Start date: June 2016
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of the study is to compare the safety and efficacy of Tafasitamab with BEN versus RTX with BEN in adult patients with relapsed of refractory DLBCL.

NCT ID: NCT02717520 Active, not recruiting - Dental Restoration Clinical Trials

Long Term Clinical Evaluation of a Posterior Glass Hybrid System vs. Composite Resin

Start date: September 2015
Phase: N/A
Study type: Interventional

The primary objective of this study is to evaluate long-term clinical performance of a glass hybrid restorative system (glass-ionomer) vs. composite resin material over a period of five years. The secondary objective is to evaluate the suitability of intraoral impressions for the assessment of wear of teeth and restorative materials over five years. For that purpose the replica method and scanning 3-D laser equipment and matching software will be used. The first null hypothesis is that there would be no difference in clinical performance between restorative materials after five years. The second null hypothesis is that wear between the restorative materials will be the same after five years. This is a multicentre, controlled clinical study conducted in Croatia, Italy, Turkey and Serbia. Eligible participants are all adults aged 18 or over with indication of restorative treatment on vital teeth in posterior molar region, limited to two surface in a healthy subjects. Exclusion criteria are presence of full dentures or crowns and bridges in occlusal contact with teeth indicated for restorative treatment, severe bruxing and unstable physiological or medical health, pregnancy and lactation, radiation therapy or using drugs. Each patient is receiving two restorative treatment (GIC-EQUIA Forte and composite resin material Tetric EvoCeram) each of which will be localized on molar teeth on either side of the mouth. Two independent examiners will evaluate the restorations at each site one week after placement and at one, two, three, four and five years according to the FDI criteria. After, three and five years recall, impressions of both restorations is taken and the casts is analysed by a 3D laser scanner.

NCT ID: NCT02629159 Active, not recruiting - Clinical trials for Rheumatoid Arthritis

A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Adults With Rheumatoid Arthritis Who Are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate

SELECT-COMPARE
Start date: December 1, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study was to assess efficacy, including inhibition of radiographic progression, and safety with upadacitinib versus placebo and versus an active comparator, adalimumab, in adults with with moderately to severely active rheumatoid arthritis (RA) who are on a stable background of methotrexate (MTX and who have an inadequate response to MTX.